Is National Drug Pricing Freedom in Europe Nearing its Expiry Date?

For more than 50 years the basic EU rules about medicines have been clear. Each member country is free to determine the price of medicines sold in its territory, and what level of reimbursement it will provide. An observer of the European Parliament discussions in February wouldn't think so, listening to the discussions on the current attempt to update the EU's so-called "transparency" rules on drug pricing and reimbursement. Many of the interventions adopted a much broader—even tangential—approach.

Let's be clear. These transparency rules—introduced 20 years ago—don't have any impact at all on the basic freedom of member states to make their own decisions. They merely set out how those decisions are reached: timeframes, criteria, information requirements, etc. The aim of the rules is to make it possible to see that decisions (whatever they may be) are reached fairly— to provide transparency about the national mechanisms used.

The update now envisaged to these rules makes it equally clear that it is not in any way attempting to encroach on those national rights about what level prices should be set or what to reimburse. It is merely trying to ensure national authorities keep to deadlines and provide information about their systems. So how, an impartial observer might ask, is it possible that so much of the debate turned to a completely different agenda?

Even allowing for political passion, it is, on the face of it, inexplicable that Alda Sousa, a left-wing Portuguese MEP, should insist that greater transparency is needed because "we should know what we are paying for and why." The state should not be "victims of the pharmaceutical industry, which always demands a high price for its medicines," he declaimed. "Manufacturers should not be allowed to impose prices unilaterally," he said, and "seek to underline member states' powers." A Polish right-wing MEP, Zbigniew Ziobro, criticized drug firms for "abusing the situation by driving prices higher in some countries and trying to influence pricing authorities."

They must know—or certainly should know—that the debate related only to technical aspects of price and reimbursement decisions, and not to the decisions themselves. So why should they waste their energies inveighing against what they see as misdeeds in entirely different terrain? Andres Perrello Rodriguez, a Spanish socialist MEP, was similarly marching to a different drum with his remarks during the debate that member states should "take account of the old and the unemployed in setting prices." That may or may not be desirable, but has nothing to do with the debate about the transparency directive. Nor does his aspiration—possibly noble in its sentiment—that "European drug pricing systems should be above and beyond financial interests, and more human."

It was to little avail that French centre-right MEP Françoise Grossetête sought to remind her colleagues that the legislation under discussion had "no impact on sovereignty," and was directed only at "removing red tape." Even her centre-right colleague Miroslav Mikolasik, from Slovakia, chose to insist that "protecting human life must be the foremost consideration, and all barriers to access must be removed"—even if this meant EU-level intervention to require standardization of prices across Europe. It is, he said, "unacceptable that prices vary from country to country." Other centre right MEPs shared some of Mikolasik's wider aspirations: "Any medicine authorized should be accessible to every citizen in all member states," demanded Petru Luhan from Romania, while his compatriot Elena Basescu said the aim should be "cheaper access for all citizens."